BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4830294 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06178
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    July 1, 2011
    Report Date
    April 30, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO A CONNECTION ISSUE WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE AND RIGHT VENTRICULAR (RV) LEAD. THE LEAD HAD OVERSENSING, WHICH RESULTED FROM INCOMPLETE INSERTION INTO THE HEADER. THE CONNECTION WAS REVISED. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379111 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| L| R D284VRC ICD